Career Possibilities Panel & Speed Networking: R&D Clinical, Regulatory, Patient Outcomes, Analytical Development

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Panelists Bios

Keith Barnett is a full time Senior Clinical and Program Operations professional within the pharmaceutical industry. He holds a BA in Communications from Seton Hall University where he was a member of the men’s baseball team. For his graduate studies Keith attended Aspen University and received his MBA and MS in Information Management. Keith is currently a Doctoral Candidate at Indiana University’s Richard M. Fairbanks School of Public Health. Keith has over 14 years of solid experience in clinical and program operations. He is currently Senior Director of Clinical Operations at Jounce Therapeutics functioning as the operations lead for the JTX-8064 program and lead projects to expand Jounce’s capabilities in a stage-appropriate manner as they advance their pipeline toward a BLA (Biologics License Application) and inspection readiness. Before Jounce Keith was most recently the Senior Director, Head of Clinical Operations at Pandion Therapeutics where he was on the department leadership team providing global strategy to the advancement of compounds while aligning with Pandion’s corporate goals and culture. Keith also had roles of increasing responsibilities at Novartis, J&J, Sanofi, and Palatin Technologies where he has been involved in global trials across twenty countries collectively. Keith has relevant experience in Phases 1-4 with direct experience with filing marketing applications and FDA inspections. He was also part of the NDA submission team that facilitated regulatory activities which resulted in FDA approval for the first in class on-demand female sexual dysfunction drug (VYLEESI) in June of 2019. When not obsessing over work/career/school Keith enjoys spending time with his wife Stephanie and two children (Kamryn 10 and Aiden 6). He is also involved in community/mentorship work in his hometowns of Newark and Irvington, New Jersey. After obtaining his doctoral degree Keith plans to use that experience to initiate public health outreach work in compromised communities in need. He also aspires to be a professor in the academia space. Keith is delighted to be a part of this panel where he can relay transferrable skills necessary to transition into the Pharma Industry.

Julie Lekstrom Himes, MD, is Vice President and Head of the Clinical Sciences, Hematology, at Takeda Pharmaceutical Company, pursuing development in multiple rare hematology indications including hemophilia, von Willebrand’s disease, and thrombotic thrombocytopenic purpura. In her twenty years in the pharmaceutical and biotech industry she has led the clinical development of innovative therapies including small molecule corrector and potentiator combinations for cystic fibrosis, and recently a CRISPR-Cas9 gene editing /autologous hematopoietic stem cell therapy, for the treatment of hemoglobinopathies. Prior to joining industry, she completed her fellowship in infectious diseases at the National Institutes of Health.

Adora Ndu, PharmD, JD, is Chief Regulatory Affairs Officer at Bridgebio Pharma, Inc. Prior to her current role she served as Group Vice President, and Head of Worldwide Research and Development (WWRD) Strategy, Scientific Collaborations and Policy at BioMarin Pharmaceutical. At BioMarin, Dr. Ndu also served as Vice President, and Head of Policy, Research, Engagement, and International, where she led a variety of Regulatory Affairs functions. Dr. Ndu is a regulatory affairs thought leader having served for many years at the Food and Drug Administration (FDA). While at FDA, Dr. Ndu was a Commander in the United States Public Health Service, and Director for FDA’s Division of Medical Policy Development where she led the development of a broad range of policies impacting the pharmaceutical and biotechnology industry. At FDA she also held leadership roles in the Office of Prescription Drug Promotion (OPDP), and was involved in FDA’s pharmacovigilance program. Dr. Ndu serves as an independent board director, and audit committee member at DBV Technologies (DBVT) and is also on the Board of Directors for the Alliance for Regenerative Medicine (ARM). Adora received her Doctor of Pharmacy degree from Howard University College of Pharmacy and her JD from the University of Maryland Carey Law School.

Huijuan Li is currently the Vice President of Analytical Development at Moderna Inc. Dr. Li oversees analytical method development, transfer, qualification and validation characterization and applications to process and product development from discovery through to regulatory filing of mRNA vaccines and therapeutics. Dr. Li played an integral part in the development of SPIKEVAX (COVID-19 Vaccine, mRNA) vaccine. Prior to join Moderna, Dr. Li was the director of analytical development within Biologics Discovery (GlycoFi Site) and later in Bioprocess Development, Merck Research Laboratory. Dr. Li oversaw method development, characterization and applications to cell line, process, and product development from early discovery through to regulatory filing for all biologic modalities. Dr. Li has been leading CMC and development teams to work closely with discovery, preclinical and clinical teams for the development of Biologics, mRNA vaccines and therapeutics at all stages, including post approval technical, strategic support and life cycle management for biologics and vaccine while working at Merck and Moderna. Dr. Li and her team have contributed to commercial filings for global approvals of two monoclonal antibodies (KEYTRUDA, ZINPLAVA) and biosimilars (insulin glargine); SPIKEVAX (COVID-19 Vaccine, mRNA) and more than 30 INDs including monoclonal antibodies, Fc-Fusion protein, PEGylated protein and mRNA therapeutics and vaccines. Huijuan received her BSc and MSc from Lanzhou university, China and received her PhD from University of Melbourne, Australia. From there she pursued her postdoctoral studies at McGill University, Montreal, Canada.

Sarah Ringuette has over 20 years of experience in pharmaceutical development including the past 10 in regulatory affairs. She recently joined Elevation Oncology as Vice President, Regulatory Affairs from Biohaven Pharmaceuticals where she was Executive Director of Regulatory Affairs and Head of Regulatory for the Kleo Pharmaceuticals subsidiary. Prior to Biohaven, she was a Principal in ICON's Strategic Regulatory Services consulting group and Global Regulatory Lead at Alexion and Bristol-Myers Squibb. She has led regulatory strategy for small molecules, biologics, and cell and gene therapies from pre-IND through market approval and post marketing in oncology, immunology, infectious disease, neurology, metabolic and compliment conditions and ophthalmology across rare, ultra rare and non-orphan indications. On her path to regulatory affairs, she was a Documentation Lead and Clinical Operations Lead at Bristol-Myers Squibb and served as a research assistant at both Memorial Sloan Kettering Cancer Center and a health outcomes policy firm. She has an MPH from Johns Hopkins University, a RAC from the Regulatory Affairs Professional Society and a BS from the George Washington University. 

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